European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, severe alopecia areata. Patients from European sites who previously completed a qualifying CTP-543 clinical trial may participate in this study.

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Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service de Dermatologie CHRU de Brest - Hopital Morvan, Brest, Finistere, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Have completed 24 weeks of treatment in a previous qualifying CTP-543 clinical trial

Exclusion criteria

Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis
Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication
Donation of blood at any point throughout the study and for 30 days after last dose of study medication

Treatment and study plan

CTP-543

Drug

Twice daily dosing

Primary outcomes

Number of Participants With Adverse Events as a Measure of Safety

Time frame: 108 weeks
Relative Change From Pre-zero Baseline in Total Severity of Alopecia Tool (SALT) Scores at Week 108

Time frame: 108 weeks

SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). This outcome measures the relative Change from Pre-zero Baseline in Total SALT Scores. Relative change from baseline was defined as 100*(post-baseline value - baseline)/baseline.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Sep 13, 2021
Registry last updated: Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed